Regional Anesthesia in Breast Surgery

Pain Clinical Trial

Official title:

Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04629612
• Other study ID #: 2020-05-001B
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Wei-Nung Teng, MD, PhD
• Phone: 886938593179
• Email: weinungteng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a trend that breast surgery can be done with peripheral nerve blockade and intravenous sedation, which reduces the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex. Common nerve block methods are paravertebral blocks and pectoral nerve blocks. By monitoring the patient's heart rate variability change and measuring the patient's parasympathetic tone, the analgesic drug can be administered according to the patient's individual differences to avoid insufficient or excessive analgesic dose. The aim of this proposal is a prospective randomized controlled clinical trial is designed to evaluate changes in analgesia nociception index (ANI), surgical pleth index (SPI), postoperative opioid demand, and pain scores between patients who received regional anesthesia and those without in breast surgery patients under non-intubated surgery.

Description:

Anesthesia has three elements: immobility, painlessness, and amnesia. To achieve these three factors depends on the balance between multiple factors, so multiple parameters need to be used for evaluation. In terms of subcortical function, pain indexes such as analgesia nociception index, surgical pleth index, etc. can be used to evaluate. By monitoring the parameters and comprehensive evaluation during the operation, the patient's condition can be fully understood. Opioids act on the central nervous system, making the nerve response slow and analgesic The effect is good, but there are many side effects, such as nausea and vomiting, drowsiness, respiratory depression, constipation, endocrine disorders, etc., and the central nervous system is suppressed by opioids, but the surrounding tissues are still damaged, releasing inflammatory mediators, causing immune dysfunction. Therefore, it is necessary to suppress inflammation and reduce the use of opioids, but also to effectively relieve pain. Nerve blockade is a powerful tool for this purpose. Local anesthetics are applied next to the nerves of the wound so that the pain signal cannot be transmitted to the central nervous system, reduce inflammatory mediators, reduce acute and chronic pain. Breast surgery can be completed by peripheral nerve blockade and intravenous sedation, which can reduce the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex, from the superficial cervical plexus, brachial nerve plexus, and thoracic vertebral nerves. At present, the commonly used nerve blocking methods include spinal nerve block, thoracic muscle block, brachial nerve block, and superficial nerve block. Blocking methods such as the cervical plexus, studies have shown that peripheral nerve blockade can reduce the amount of opioid analgesics during surgery. This research plan is to design a randomized clinical trial to observe changes in the analgesic injury index (ANI), surgical pleth index (SPI), intraoperative and postoperative opiate demand, pain index, etc. inpatients with or without regional anesthesia under non-intubated breast surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Breast neoplasm require surgical resection of tumor
• Surgical type: non-intubated breast surgery under intravenous anesthesia

Exclusion Criteria:

• Contraindication for regional anesthesia: coagulopathy, infection
• Previous breast surgery
• Body mass index > 40
• Chronic opioid use
• Allergy to intravenous and regional anesthesia agents: Propofol, remifentanil, bupivacaine

Related Conditions & MeSH terms

• Analgesia
• Breast Neoplasms
• Pain
• Regional Anesthesia

Intervention

Procedure:
• Regional anesthesia
Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	From start of post operative care unit to discharge from post operative care unit, up to two hours
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	Second to 12th hour postoperatively
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	12th to 24th hour postoperatively
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	24th to 36th hour postoperatively
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	36th to 48th hour postoperatively
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	48th to 60th hour postoperatively
Primary	Post-operative opioid use	Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent	60th to 72nd hour postoperatively
Secondary	Intra-operative opioid use	Total dose of intra-operative remifentanil	From start of induction to completion of surgery, total of 1-2 hours
Secondary	Intra-operative analgesia nociception index	Intra-operative measurement of analgesia nociception index, on a scale on 0-100, higher on the scale indicate higher parasympathetic tone	From start of induction to completion of surgery, total of 1-2 hours
Secondary	Intra-operative surgical pleth index	Intra-operative measurement of surgical pleth index, on a scale on 0-100, lower on the scale indicate higher parasympathetic tone	From start of induction to completion of surgery, total of 1-2 hours
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	Second postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	6th postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	12th postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	24th postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	36th postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	48th postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	60th postoperative hour
Secondary	Post-operative nurse rated pain scale	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level	72nd postoperative hour